MAUDE Adverse Event Report: DJO LLC CMF; OL1000 DUAL COIL

Catalog Number	01-203-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that 56-year-old male presents to urgent care with a open sore on his left foot a t week after he used his stimulator on the area.Patient was seeing wound center for an open sore in the area but was discharged recently.The device has not been returned for evaluation, the root cause could not be confirmed additional reporting on this event will be provided as a supplemental report to this document if more information becomes available.
Event or Problem Description
It was reported that 56-year-old male presents to urgent care with a open sore on his left foot a t week after he used his stimulator on the area.Patient was seeing wound center for an open sore in the area but was discharged recently.

• Brand Name: CMF
• Common Device Name: OL1000 DUAL COIL
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer Contact: mitchell dhority ; 5919 sea otter place; ste 200; carlsbad, ca 92010 ; MX 92010
• MDR Report Key: 25538355
• Report Number: 9616086-2026-00024
• Device Sequence Number: 15870714
• Product Code: LOF
• UDI-Device Identifier: 00888912011488
• UDI-Public: 00888912011488
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 01-203-0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male